Regulatory Affairs Manager - CMC

Amgen Foundation, Inc.; United States; Remoto; USD 140.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits package

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off

Flexible work models

Descrizione del lavoro

Amgen Inc. is seeking a Regulatory Affairs Manager - CMC in the United States. In this vital role, you will strategize and execute site-specific CMC regulatory activities, coordinating with global teams to ensure compliant filings for post-market supplements and facility registrations.

You will provide regulatory inputs and assess deviations to shape strategy. You will drive regulatory submissions, develop post-approval variations, and ensure ongoing compliance through appropriate filings, with

Competenze

• Doctorate or equivalent in a life sciences field with regulatory science focus.
• Experience in regulatory CMC within pharma/biotech.
• Knowledge of ICH guidelines and GMP/GCP requirements.
• Experience preparing regulatory dossiers per CTD structure.
• Strong regulatory strategy and post-market submission skills.

Mansioni

• Define regulatory filing requirements for postapproval programs.
• Develop regulatory strategy via MASP and/or GIRS.
• Develop post-approval variations and maintain applications.
• Coordinate with site functions for regulatory filings and deviations.
• Provide impact assessments with input from CMC teams and regional reps.
• Support Change Management activities as needed.
• Respond to agency questions and prepare briefing documents.
• Collaborate with cross-functional teams to align global regulatory strategies.

Conoscenze

Regulatory strategy

CMC regulatory affairs

Cross-functional collaboration

Regulatory submissions

Formazione

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Descrizione del lavoro

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regulatory Affairs Manager - CMC

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations. You will interface with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity and provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative.

You will serve as Regulatory CMC voice for product teams byproviding the following services:

• Define minimum regulatory filing requirements for postapproval programs

• Provide regulatory strategy through development ofMASPand/or GIRS

• Development ofpost approval variations

• Maintenance of applications (Annual Reports, DistributionReports, Annual Stability updates)

• Maintain productcompliance through appropriate regulatoryfilings and activities includingregulatory commitments

• Provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative

• Support Change Management activities as needed

• Respond to regulatory agency questions

• Facilitate agency interactions, including meetingpreparation, meetings and briefing documents

• Liaise with other Functions in development, operations,and commercial to ensure alignment of global regulatorystrategies, timing, execution and plans

• Contribute to the PDT’s Variation Master Plan as required

• Participate as an active member of cross-functional teams

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 2 years of Regulatory Affairs experience

OR

Bachelor’s degree and 4 years of Regulatory Affairs experience

OR

Associate’s degree and 8 years of Regulatory Affairs experience

OR

High school diploma / GED and 10 years of Regulatory Affairs experience

Preferred Qualifications:

• Degree in a life sciences discipline, or equivalent relevant experience.

• Experience in Regulatory CMC within the pharmaceutical or biotechnology industry.

• Working knowledge of ICH guidelines and current GMP and GCP requirements.

• Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure.

• Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retailation and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.